Status:
TERMINATED
A Phase II Clinical Trial of TQC3721 Suspension for Inhalation
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
TQC3721 suspension for inhalation is a PDE3/4 inhibitor developed by Chia Tai Tianqing Pharmaceutical Group Co., LTD., which can simultaneously achieve bronchial smooth muscle relaxation and anti-infl...
Eligibility Criteria
Inclusion
- 1 Sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the test;
- 2 Capable of using the study nebulizer correctly and complying with all study restrictions and procedures;
- 3 Aged between 18 and 75 years old, both men and women;
- 4 Body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value) and body weight is ≥45kg;
- 5 Subjects have no pregnancy plan and have voluntarily taken effective contraceptive measures for at least 1 month after being screened to the last use of the study drug;
- 6 12-lead electrocardiogram with QT interval corrected ≤450 msec (males) or ≤470 msec (females), QRS interval ≤120 msec, PR interval ≤200 msec and no morphologic and other clinical significant abnormalities that the investigator considered inappropriate for the study;
- 7 Ability to perform acceptable and reproducible spirometry;
- 8 Patients previously treated with LAMA or LABA who had evidence of stable use for at least 3 months prior to screening and agreed to continue use during the study period;
- 9 Capable of withholding LAMA or LABA（ Twice-Daily maintenance LAMA or LABA for at least 24 hours and Once-Daily maintenance LAMA or LABA for at least 48 hours) and SAMA、SABAs（at least 4 hours）prior to initiation of any spirometry;
- 10 According to the 2020 GOLD Guidelines, Post-bronchodilator spirometry at screening must demonstrate FEV1/FVC ratio of ≤0.70 and FEV1 must be ≥30 % to ≤80% of predicted normal;
- 11 Current or former cigarette smokers with a history of cigarette smoking ≥10 pack years (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years, former cigarette smokers should stop smoke at least 6 months before visit 1).
Exclusion
- 1 Intolerance to salbutamol or this product.
- 2 ≥1 hospitalization for COPD treatment within 6 months prior to screening.
- 3 Antibiotic treatment for lower respiratory tract infection within 3 months prior to screening.
- 4 Use of prohibited medications within the time intervals.
- 5 Patients who were currently diagnosed with asthma, active tuberculosis, lung cancer and other active lung diseases and were considered unsuitable for the study.
- 6 Previous lung resection or lung reduction surgery.
- 7 Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Screening and remains stable during the study.
- 8 A history of drug or alcohol abuse in the past 3 years (14 units of alcohol consumed per week: 1 unit =360 ml of beer or 45 ml of 40% alcohol spirits or 150 ml of wine).
- 9 Have participated in a clinical trial within one month prior to screening or within 5 half-lives of the investigational drug, whichever is the longer.
- 10 Women who are breast-feeding.
- 11 A history of myocardial infarction, congestive heart failure, and unstable or uncontrolled hypertension (systolic blood pressure ≥160mmHg and diastolic blood pressure ≥100mmHg after drug control) within 6 months prior to screening.
- 12 History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin.
- 13 Alanine aminotransferase (ALT) or aspartate aminotransferase(AST)≥ 2 x upper limit of normal (ULN), or other abnormal test results were deemed unsuitable for inclusion by the investigator.
- 14 Required use of oxygen therapy, even on an occasional basis.
- 15 Other conditions that the investigator considered inappropriate for participation in the study.
Key Trial Info
Start Date :
May 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT05292196
Start Date
May 20 2022
End Date
December 5 2023
Last Update
April 20 2025
Active Locations (11)
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1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000
2
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730700
3
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China, 524023
4
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001